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8-K - 8-K - T2 Biosystems, Inc.a15-11163_18k.htm
EX-99.2 - EX-99.2 - T2 Biosystems, Inc.a15-11163_1ex99d2.htm

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

T2 Biosystems Reports 2015 First Quarter Results

 

LEXINGTON, Mass. May 5, 2015T2 Biosystems (NASDAQ:TTOO) today reported operating highlights and financial results for the first quarter ended March 31, 2015. Recent operational highlights included:

 

·                  The Company secured two customer contracts and one completed installation for the T2Candida® Panel and T2Dx® Instrument

·                  Results from an analysis of the impact of using the Company’s T2Candida Panel were published in Future Microbiology. The study found that in a 500-bed hospital with an average of 5,100 symptomatic patients at high risk for developing a Candida infection, early detection with the utilization of T2Candida could provide an annual cost savings of approximately $5.8 million and the prevention of 60 percent of Candida-related deaths.

·                  The Company entered into a multiyear, strategic agreement with Canon U.S. Life Sciences, Inc. to jointly develop a novel diagnostic test to rapidly detect Lyme disease

·                  Results from the first large, multicenter clinical trial for the T2Candida Panel and the T2Dx Instrument were published in Clinical Infectious Disease and demonstrated 91.1% sensitivity and specificity of 99.4 percent for sepsis pathogen detection in three to five hours without the need for blood culture

·                  An article supporting the use of T2MR® as a platform with the potential to significantly impact the field of diagnostics was published in The Journal of the American Medical Association (JAMA)

 

“We are delighted to report that we secured initial customer contracts for our T2Candida Panel and the T2Dx Instrument, and we are very encouraged by the number of institutions who are now in the later stages of the adoption process,” said John McDonough, president and CEO of T2 Biosystems. “The most recent publication in Future Microbiology has provided our growing sales team additional peer-reviewed evidence of the significant cost and life savings of the T2Candida Panel, which is critical given the increasing demand for improved efficiency and outcomes in the hospital setting.”

 

Financial Results

 

In the first quarter of 2015, the Company generated revenue primarily from research and development agreements, as well as nominal revenue from the sale of products. Total revenue in the first quarter of this year was $188,000 which primarily consisted of revenue related to co-development efforts with third parties. The Company did not record any revenue in the first quarter of 2014.

 

Total operating expenses for the first quarter of 2015 were $10.3 million compared to $6.9 million for the first quarter of 2014. The increase in operating expenses was mainly

 



 

associated with research and development activities for additional applications of T2MR, expansion of marketing programs, build-out of the U.S. commercial infrastructure, and increases in share-based compensation charges and incremental expenses related to being a public company.

 

The net loss applicable to common shareholders for the first quarter of 2015 was $10.6 million, or $0.53 loss per share, compared to $8.8 million (after adjustments for accretion of redeemable convertible preferred stock), or $6.25 loss per share for the first quarter of 2014. The increased loss was principally due to the increased operating expenses noted above. The loss per share calculation for the first quarter was impacted by the overall increase in common shares outstanding resulting from the August 7, 2014 initial public offering.

 

The Company’s balance sheet as of March 31, 2015, showed total cash and cash equivalents of $65.3 million.

 

Conference Call

 

T2 Biosystems’ management will discuss the Company’s financial results for the first quarter ended March 31, 2015, and provide a general business update during a conference call beginning at 4:30 p.m. Eastern Time today, Tuesday, May 5, 2015. To join the call, participants may dial 1-877-407-4018 (U.S.) or 1-201-689-8471 (International). To listen to the live call via T2 Biosystems’ website, go to www.t2biosystems.com, in the Events & Presentations section. A webcast replay of the call will be available for 30 days following the conclusion of the call in the Events & Presentations section of the website.

 

About T2 Biosystems

 

T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company’s diagnostic products and

 



 

the ability to bring such products to market. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as supplemented or amended from time to time under “Item 1A.—Risk Factors” in our Quarterly Reports on Form 10-Q, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

 

Media Contact:

Katie Engleman, Pure Communications

katie@purecommunicationsinc.com

910-509-3977

 

Investor Contact:

Matt Clawson, Pure Communications

matt@purecommunicationsinc.com

949-370-8500

 

-     Tables to Follow —

 



 

T2 Biosystems, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Quarter Ended

 

Quarter Ended

 

 

 

March 31, 2015

 

March 31, 2014

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

Product revenue

 

$

10

 

$

 

Research revenue

 

178

 

 

Total revenue

 

188

 

 

Costs and expenses:

 

 

 

 

 

Cost of product revenue

 

3

 

 

Research and development expenses

 

5,868

 

5,065

 

Selling, general and administrative expenses

 

4,468

 

1,842

 

Total costs and expenses

 

10,339

 

6,907

 

Loss from operations

 

(10,151

)

(6,907

)

Interest expense, net

 

(477

)

(86

)

Other income, net

 

9

 

73

 

Net loss

 

$

(10,619

)

$

(6,920

)

Comprehensive Loss

 

$

(10,619

)

$

(6,920

)

Reconciliation of net loss to net loss applicable to common stockholders:

 

 

 

 

 

Net loss

 

$

(10,619

)

$

(6,920

)

Accretion of redeemable convertible preferred stock to redemption value

 

 

(1,906

)

Net loss applicable to common stockholders

 

$

(10,619

)

$

(8,826

)

Net loss per share applicable to common stockholders - basic and diluted

 

$

(0.53

)

$

(6.25

)

Weighted-average number of shares of common stock used in computing net loss per share applicable to common stockholders — basic and diluted

 

20,080,515

 

1,411,961

 

 



 

T2 Biosystems, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 

 

 

March 31, 2015

 

December 31,
2014

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

65,295

 

$

73,849

 

Accounts receivable

 

88

 

201

 

Prepaid expenses and other current assets

 

686

 

1,076

 

Inventories

 

252

 

115

 

Restricted cash

 

80

 

80

 

Total current assets

 

66,401

 

75,321

 

Property and equipment, net

 

5,332

 

2,760

 

Restricted cash, net of current portion

 

260

 

260

 

Deferred tax assets

 

313

 

313

 

Other assets

 

468

 

480

 

Total assets

 

$

72,774

 

$

79,134

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,173

 

$

735

 

Accrued expenses

 

3,426

 

3,662

 

Notes payable

 

300

 

295

 

Deferred revenue

 

2,029

 

80

 

Deferred tax liabilities

 

313

 

313

 

Lease incentives

 

214

 

87

 

Total current liabilities

 

7,455

 

5,172

 

Notes payable, net of current portion

 

20,592

 

20,660

 

Lease incentives, net of current portion

 

995

 

106

 

Other liabilities

 

252

 

195

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued

 

 

 

Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2015 and December 31, 2014; 20,198,969 and 20,041,645 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively

 

20

 

20

 

Additional paid-in capital

 

157,673

 

156,576

 

Accumulated deficit

 

(114,213

)

(103,595

)

Total stockholders’ equity

 

43,480

 

53,001

 

Total liabilities and stockholders’ equity

 

$

72,774

 

$

79,134

 

 

###